Impact of concomitant cardiac procedures performed during implantation of long-term left ventricular assist devices.

There is a paucity of data evaluating the effect of performing a concomitant cardiac procedure (CCP) on peri-operative survival in patients undergoing implantation of long-term left ventricular assist devices (LVADs). The objective of this study was to review our single-institutional experience with patients who underwent a CCP during implantation of a long-term continuous-flow LVAD. From March 2006 through June 2012, 130 patients underwent implantation of a LVAD. Of these, 76 (58.5%) were implanted as bridge-to-transplant and 54 (41.5%) as destination therapy. The LVAD implantation was isolated in 95 patients and with CCP in 35. This included 19 tricuspid valve repairs, 14 aortic valve repair/replacements, and 2 patent foramen ovale closures. The LVAD only and LVAD+CCP groups were compared regarding pre-operative demographics, peri-operative and midterm survival, and the incidence of post-operative complications. Pre-operative central venous pressure (p = 0.047), moderate to severe tricuspid regurgitation (p = 0.011), cardiopulmonary bypass time (p < 0.0001), cross-clamp time (p < 0.0001), and right ventricular end diastolic diameter (p = 0.039) were higher in the CCP group. Body mass index (p = 0.01) and body surface area (p = 0.037) were higher in the LVAD-only group. Peri-operative and midterm survival at 30 days, 6 months, 1 year, and 2 years was 94%, 87%, 80%, and 73%, respectively, for isolated LVAD implants vs. 97%, 90%, 86%, and 86%, respectively, for LVAD+CCP (p = NS). Survival was similar for LVAD patients with tricuspid valve repairs, with aortic valve repair, and with patent foramen ovale repair (p = NS). Cox proportional hazard models showed a CCP was not an independent predictor of outcome (p = NS). CCPs performed during implantation of a long-term continuous-flow LVADs does not increase peri-operative or mid-term mortality. In addition, unlike previous reports, there was no additive procedural risk for patients undergoing concomitant aortic valve repair or replacement.

Morgan JA ，Tsiouris A ，Nemeh HW ，Hodari A ，Karam J ，Brewer RJ ，Paone G ... -  《-》

Impact of concurrent surgical valve procedures in patients receiving continuous-flow devices.

Preexisting valve pathology is common in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) placement. The indications and subsequent benefits of performing valvular procedures in these patients are unclear. The objective of this study was to determine the impact of performing concurrent surgical valve procedures in a large cohort of patients receiving LVADs. One thousand one hundred six patients received the HeartMate II (HMII) LVAD in the bridge to transplant (n = 470) and destination therapy (n = 636) clinical trials. Of these, 374 patients (34%) had concurrent cardiac surgery procedures as follows: 242 patients (21%) with 281 concurrent valve procedures (VP) (aortic 80, mitral 45, and tricuspid 156), and 641 patients had only HMII LVAD. The focus of this study was to determine the clinical outcomes of patients undergoing HMII + VP compared with those who received HMII alone. Patients undergoing HMII + VP were significantly older, had higher blood urea nitrogen levels and central venous pressure, and decreased right ventricular stroke work index; intraoperatively, the median cardiopulmonary bypass times were also longer. The unadjusted 30-day mortality was significantly higher in patients undergoing HMII + VP (10.3% vs 4.8% for LVAD alone, P = .005). Subgroup analysis of individual VPs showed that higher mortality occurred in patients with HMII plus 2 or more VPs (13.5%, P = .04) followed by trends for increased mortality with HMII plus mitral alone (11.5%, P = NS), HMII plus aortic alone (10.9%, P = NS), and HMII plus tricuspid (8.9%, P = NS) procedures. Of these various groups, only patients undergoing HMII + isolated aortic VP (P = .001) and HMII + multiple VPs (P = .046) had significantly worse long-term survival compared with patients undergoing HMII alone. Right heart failure and right ventricular assist device use was increased in patients undergoing VPs, but there was no difference in the incidence of bleeding or stroke. Patients frequently require concurrent VPs at the time of LVAD placement; these patients are sicker and have higher early mortality. Furthermore, right ventricular dysfunction is increased in these patients. Further studies to develop selection criteria for concurrent valve interventions are important to further improve clinical outcomes.

John R ，Naka Y ，Park SJ ，Sai-Sudhakar C ，Salerno C ，Sundareswaran KS ，Farrar DJ ，Milano CA ... -  《-》

Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures.

Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail. Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.6%) underwent isolated HeartWare Ventricular Assist Device implantation, 75 (19.6%) a concurrent valve procedure, and 45 (11.8%) concurrent nonvalvular procedures. Of the concurrent valve procedures, 56 were tricuspid, 13 aortic, and 6 mitral. Survival was similar between groups (79% for concurrent valve procedures and 85% for HeartWare Ventricular Assist Device only at 1 year; P=0.33). Concurrent valve procedures were also associated with increased unadjusted early right heart failure (RHF). A multivariable analysis for death and RHF (121 total events) identified female sex (odds ratio=2.0 [95% confidence interval, 1.2-3.3; P=0.0053]) and preimplant tricuspid regurgitation severity (odds ratio=2.9 [95% confidence interval, 1.8-4.8, P<0.0001]) as independent predictors while concurrent tricuspid valve procedures (TVP) were not predictors. Furthermore, patients with significant preimplant tricuspid regurgitation who did not receive a TVP experienced an increased rate of late RHF compared with those who received TVP (0.19 versus 0.05 events per patient-year, respectively; P=0.024). Compared with HeartWare Ventricular Assist Device alone, survival was equivalent for the concurrent valve procedure group. Tricuspid regurgitation severity was the most important predictor of increased postoperative RHF, and concurrent TVP was not an independent predictor of RHF overall. Concurrent TVP may reduce the rate of late RHF for patients with significant preimplant tricuspid insufficiency. http://www.clinicaltrials.gov. Unique identifier: NCT00751972.

Milano C ，Pagani FD ，Slaughter MS ，Pham DT ，Hathaway DR ，Jacoski MV ，Najarian KB ，Aaronson KD ，ADVANCE Investigators ... -  《-》

Durability and clinical impact of tricuspid valve procedures in patients receiving a continuous-flow left ventricular assist device.

Patients evaluated for a continuous-flow left ventricular assist device frequently present with severe right ventricular dysfunction with tricuspid regurgitation. Long-term outcomes of concurrent tricuspid valve procedures in continuous-flow left ventricular assist device implantation are unclear. From May 2004 to December 2013, 336 patients received continuous-flow left ventricular assist devices. Among these, 8 patients with prior tricuspid valve procedures were excluded. At continuous-flow left ventricular assist device implantation, 76 patients underwent tricuspid valve procedures (group A), including 68 repairs and 8 replacements. The remaining 252 patients did not receive concurrent tricuspid valve procedures (group B). Preoperatively, group A had higher central venous pressure/pulmonary capillary wedge pressure (P = .032), total bilirubin (P = .009), and percentage of moderate or greater tricuspid regurgitation (98.7% vs 18.8%; P < .001). In group A, cardiopulmonary bypass time (136 ± 52.0 minutes vs 83.9 ± 38.8 minutes; P < .001), intraoperative platelet use (13.6 ± 6.70 units vs 11.7 ± 5.92 units; P = .042), and bleeding requiring reoperation (27.5% vs 16.7%; P = .046) were significantly increased. In-hospital mortality was similar (10.5% vs 6.4%; P = .22). On-device 2-year survival was 73.9% in group A and 74.2% in group B (P = .24). At 2 years, mean cumulative readmissions for right heart failure was 0.21 in group A and 0.27 in group B (P = .95). A generalized linear mixed-effects model showed that tricuspid valve procedures are protective for developing future significant tricuspid regurgitation (odds ratio, 0.38; 95% confidence interval, 0.19-0.76; P = .006). Concomitant tricuspid valve procedures at continuous-flow left ventricular assist device implantation can be performed safely and are protective against worsening tricuspid regurgitation during the first 2 years of support.

Han J ，Takeda K ，Takayama H ，Kurlansky PA ，Mauro CM ，Colombo PC ，Yuzefpolskaya M ，Fukuhara S ，Truby LK ，Topkara VK ，Garan AR ，Mancini DM ，Naka Y ... -  《-》

Impact of tricuspid valve annulus dilation on mid-term survival after implantation of a left ventricular assist device.

After left ventricular assist device (LVAD) implantation, right ventricular (RV) failure is a major cause of post-operative morbidity and mortality. Recently, in patients with similar hemodynamic challenge, but less severe RV impairment, who were undergoing surgery for mitral valve repair, concomitant tricuspid valve repair improved post-operative RV re-remodeling in patients with severely dilated tricuspid annuli without tricuspid regurgitation (TR). Pre-operative transesophageal echocardiography and clinical data were prospectively collected from 122 patients without severe TR, who were selected for LVAD implantation. Patients were assigned to one of two groups according to pre-operative tricuspid annulus diameter <43 mm or >43 mm. Groups were compared for parameters that may impact survival after LVAD implantation. Kaplan-Meier survival curves were evaluated for the impact of tricuspid annulus size and right-to-left ventricular diameter ratio (R/L ratio) on 36-month survival. Multivariate analysis was used to identify the pre-operative parameters that independently affected survival. Patients with tricuspid annulus >43 mm presented with higher R/L ratio (0.73 ± 0.21 vs 0.56 ± 0.13; p < 0.00001) and higher proBNP plasma concentration (12,872 ± 13,084 vs 8,988 ± 13,018 pg/ml; p = 0.018). Both R/L ratio >0.72 and tricuspid annulus >43 mm adversely affected survival (p = 0.003 and 0.007, respectively). In the multivariate analysis only tricuspid annulus diameter >43 mm (hazard ratio 2.16, CI 1.21 to 3.84, p = 0.009) and age (hazard ratio 1.03, CI 1.00 to 1.06, p = 0.04) were independent predictors of survival after LVAD. Tricuspid dilation, even without severe regurgitation, adversely affects survival after LVAD implantation. Further studies are required to determine whether concomitant tricuspid valve repair may improve survival in these patients.

Kukucka M ，Stepanenko A ，Potapov E ，Krabatsch T ，Kuppe H ，Habazettl H ... -  《-》